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Tethered Capsule Endomicroscopy for Barrett's Esophagus

N/A

Waitlist Available

Led By Guillermo Tearney, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy

Be older than 18 years old

Must not have

Subjects with esophageal fistula and/or esophageal strictures

Subjects with prior endoscopic ablation or resection treatment of BE at enrollment visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a tethered capsule endomicroscopy device can help doctors detect and treat Barrett's Esophagus.

Who is the study for?

This trial is for adults over 18 with Barrett's Esophagus (BE) but without severe cell changes or esophageal cancer. Participants must not eat solid food for at least 4 hours and only clear liquids for 2 hours before the procedure. They should be able to swallow capsules, give informed consent, and have had a standard EGD within the past 15 months.

What is being tested?

The study tests Tethered Capsule Endomicroscopy (TCE), a less invasive way to monitor Barrett's Esophagus using a capsule device with imaging technology. Patients will be followed up for three years at multiple sites to see how well TCE works in detecting changes in the esophagus.

What are the potential side effects?

Potential side effects of TCE may include discomfort from swallowing the capsule, gagging, or choking if difficulty swallowing occurs. There might also be risks associated with sedation if used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Barrett's esophagus without severe changes or cancer, confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an esophageal fistula or stricture.

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I have had a procedure to remove or destroy Barrett's esophagus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental OFDI capsule imagingExperimental Treatment1 Intervention

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system. Intervention: 'Tethered Capsule Endomicroscopy (TCE) Imaging of Barrett's esophagus using OFDI capsule

0 / 3Eligibility criteria met